Innovent Biologics, Inc. („Innovent“) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that China’s National Medical Products Administration (NMPA) has approved Dupert®?fulzerasib?for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. As China’s first approved KRAS G12C inhibitor, Dupert® is Innovent’s eleventh product in its commercial portfolio and is anticipated to soon benefit more lung cancer patients with the KRAS G12C mutation.
Lung cancer has one of the highest incidence and mortality rates worldwide, with non-small cell lung cancer (NSCLC) being the most common type, comprising about 85% of all lung cancer cases. KRAS mutations are common driver gene mutations in NSCLC but rarely co-exist with other driver mutations like EGFR and ALK. As a result, patients with advanced NSCLC and KRAS G12C mutations often cannot benefit from the multiple drugs currently available that target these mutations or rearrangements. After the initial standard treatment for this population, there are limited second-line options, which have low effectiveness and poor prognosis.
The NDA approval is based on the results from a single-arm registrational Phase 2 clinical study (NCT05005234) intended to evaluate the efficacy and safety of fulzerasib monotherapy in advanced NSCLC patients with KRAS G12C mutation who failed or were intolerant to the standard treatment in China. The updated data from this registration study has been published in full manuscript in the Journal of Thoracic Oncology (JTO).
